CLASS II Device recall · Reported 29 Jul 2015 · FDA Enforcement Report
M-Biopsy Coaxial Introducer Needle, Coaxial Needle recalled
Mermaid Medical A/S is recalling Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy, distributed in Florida, Puerto Rico. The recall was initiated on 15 Jun 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2190-2015
- FDA event ID
- 71525
- Recalling firm
- Mermaid Medical A/S, Stenl?se, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2015
- FDA classified
- 22 Jul 2015
- Reported
- 29 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 15 Jun 2015 | Recall initiated by company | |
| 22 Jul 2015 | Classified by FDA | +37 days |
| 29 Jul 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.
Where it was distributed
US Distribution to FL including PR.
Questions about this recall
Is M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-Pro-mag recalled?
Yes. Mermaid Medical A/S recalled M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-Pro-mag on 15 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-2190-2015.
Why was it recalled?
Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula.
Which lots are affected?
Lot No: P000290, P000360, P000230, P000291, P000299, P000148 Catalogue No: N20314010- N20320020 (for PRO-MAG Biopsy Instrument) Catalogue No: N20414010- N20420020 (for MAGNUM Biopsy Instrument)
Where was it sold?
US Distribution to FL including PR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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